The establishment of the FOSHU approval process was intended to encourage the
development of functional foods that could benefit the public's health while responding to the
concerns of consumer groups (and some leading food companies) about misleading health claims.
It is doubtful whether either goal has been achieved.

A. It is Questionable Whether Most FOSHU-Approved Products are Truly Benefitting the Health of Consumers.

Most FOSHU-approved products purchased by consumers fail to address the health
concerns of most importance to the Japanese population.

While some popular FOSHU-approved foods address serious problems in the Japanese diet
such as inadequate calcium and fiber consumption, the best-selling FOSHU-approved ingredients,
comprising the vast majority of sales, are designed to improve digestion, not reduce the risk of
serious chronic diseases.(12) By contrast, FOSHU-approved products designed for people with
moderately high blood pressure comprise only 1% of sales despite the fact that high blood pressure
is a major public health problem (Table 5).

Furthermore, the popularity of many functional foods appears to be short-lived and based on
fads. In 1995, for example, there was a sudden and short-lived popularity of gymnema tea. In
1996, there was a consumer rush for cocoa and cocoa-based products when a television program
claimed that such products could lower cholesterol. Demand for cocoa increased suddenly by
24%.(13) Most recently, short-lived fads were seen with the promotion of collagen (for skin care),
anthocyanins (to relieve eyestrain) and lycopene (to reduce the risk of cancer).(14) The promotion of
such products may do little to protect the public health and often confuses the messages of health
professionals concerning how consumers can best improve their diet and protect their health.
Overall, the FOSHU system has had little effect on reducing the incidence of serious public health
problems.(15)

Some FOSHU-approved products are sold in the form of confectionery, soft drinks, and
other snack foods.(16)

When deciding whether to grant a FOSHU approval, the MHW only considers fat, sodium,
and sugar content if the levels of these nutrients directly contradict the benefit provided by the
functional ingredient.(17) The government approval of such products may send a mixed nutritional message to consumers that junk foods can still be healthy.(18)

The health effects of some FOSHU-approved products are unproven.

The MHW's review process is much looser than that for medicines subject to the
Pharmaceutical Affairs Law.(19) FOSHU applications often include the results of clinical trials and
other studies.(20) But, according to an independent review that was conducted of studies relied upon
by the MHW to grant FOSHU approvals, a number of products were approved without adequate
scientific support. Reviewers asked 40 companies that had received FOSHU approvals as of 1997
to disclose the scientific studies that they included in their FOSHU applications. Eighteen of the 40
companies responded. The effectiveness of only some functional components -- lactulose, calcium
citrate malate, and heme iron -- were demonstrated by double-blind clinical trials. Moreover, 53 out
of a total of 61 studies examined did not even include control groups, rendering the studies almost
worthless. The majority of studies consisted of a simple comparison of health conditions before and
after the intake of a functional component. Furthermore, the studies generally were small,
involving, on average, only 28 people. Seven studies did not involve humans at all, but rather were
performed on laboratory rats.(21)

It is difficult for independent scientific experts to evaluate the standards used by the MHW for FOSHU approvals.

The precise level of substantiation required by the MHW for FOSHU approvals is not
known.(22) The Ministry has not announced what standards it will apply. Furthermore, there is no
opportunity for public comment or outside scientific review of MHW approvals prior to the time
that they are finalized.(23) It is thus extremely difficult for outside scientific experts to evaluate
decisions of the MHW.

Prior to the 1998 amendments to the FOSHU law, the Japan Health Food & Nutrition Food
Association (JHNFA) helped speed FOSHU approvals by establishing its own approval system
parallel to, but separate from, that of the MHW. Working groups within the association reviewed
research on new functional ingredients and summarized the scientific evidence. An academic
committee of the association, consisting of three senior professors, then evaluated the information
compiled and made a recommendation. This recommendation helped companies to obtain a
certificate indicating that all scientific evidence in the application was reviewed by outside experts.
The recommendation provided by the association thus had a strong influence on the Ministry, and
applications prepared in this manner were typically approved several months after they were
submitted.(24)

Since the law was amended in 1998, the role of the JHNFA has changed. The MHW
eliminated the requirement that companies certify that scientific evidence in an application was
reviewed by outside experts and instead began requiring that studies supplied by companies be
published in an academic journal.(25) To help companies get their studies published, the JHNFA
created a new publication in 1998 called the Journal of Nutritional Food.(26) Rules for submitting
articles to the journal stipulate that, in general, the company sponsoring the study submitted for
publication should be a member of the JHNFA and that at least one of the authors of the study
should work for the member company. The rules state that exceptions to this requirement can be
granted in specific situations, and the journal does publish other articles related to nutrition.

Nonetheless, it appears that the JHNFA began publishing the journal last year primarily to
provide its members with a vehicle to meet the publication requirement instituted by the MHW.
While the rules of the journal require articles to be reviewed by a committee before they are
published, it appears that the journal was created to provide a forum for publishing studies that
might not have been accepted for publication in scientific journals published by professional
associations or other independent institutions.

The MHW, however, regards the Journal as an academic publication. While the MHW has promised to critically evaluate studies published in the Journal, it generally views such studies as
reliable.(27)

B. The Establishment of the FOSHU System has not Eliminated Misleading Claims for Functional Foods.

Most health foods are not FOSHU-approved.

Because the FOSHU system is voluntary, companies still market more than 1,000 functional
foods that are not FOSHU-approved. Some companies, generally smaller ones, simply make
express health claims for unapproved products in violation of the law. For example, in 1996, a
company, without gaining FOSHU approval, launched a mushroom extract which it promoted as
helping to fight cancer, HIV, and aging. More recently, the Consumer Information Center reported
that health tea drinks that tout the presence of senna stems contain senna leaf which is designated as
a medicine under the Pharmaceutical Affairs Law.(28) Government regulators, confronted with an
avalanche of new products each month, find it impossible to police the marketplace effectively.(29)

Larger companies generally refrain from making express health claims for unapproved
products, but still imply that such products have specific health benefits by promoting the presence
of the functional ingredient. According to analysts who have examined the Japanese marketplace,
the use of an express health claim on the product label is not necessary for the successful marketing
of a functional food in Japan.(30) Thus, many companies simply avoid the FOSHU system and
succeed by making what are, in essence, unapproved implied health claims by emphasizing the
presence of ingredients such as DHA, lycopene, and beta-carotene.

What is clear is that FOSHU-approved foods constitute only a small fraction of the
marketplace(31) and that consumers spend billions of dollars on non-FOSHU-approved products in
the hope that such products may benefit their health.(32) Indeed, in Japan, unapproved functional
foods seem to cover almost every known ailment from bad breath to stress. Even Suntory, Japan's
largest liquor distiller, sells a sesame-based product called Sesamin that is promoted as helping to
prevent hangovers. Reliance on such products to improve health may often be misplaced.

Functional foods sold outside the FOSHU system are simply marketed as health foods.
There is no law defining health foods, and manufacturers are free to market any food as a health
food as long as they do not violate the Food Hygiene Law or Pharmaceutical Affairs Law.
Unfortunately for the consumer, many such foods do violate the law. The municipal government of
Tokyo examined 56 products that are widely sold in health-food stores. They found that 600
violated the law. Twenty-nine of the 56 products specifically violated the Pharmaceutical Affairs
Law by making unapproved health claims. Only six products were in full compliance with the Pharmaceutical Affairs law, the Food Hygiene Law, and the Nutrition Improvement Law (the latter
requires companies to provide nutrition information if they make nutrition claims).(33)

The JHNFA sets manufacturing standards as well as criteria for labeling and advertising of
health foods. More than 1,200 brands of foods carried the JHNFA seal as of July 1997.(34) For
example, the JHNFA certifies health foods containing beta-carotene. The marketing of soft drinks
with added beta-carotene illustrates problems with health foods sold outside the FOSHU system and
subject only to self-regulation. Many companies began to sell such beverages in Japan after
preliminary scientific studies revealed that diets rich in fruits and vegetables containing beta-carotene were associated with a lower rate of cancer. Some companies expressly claim that beta-carotene can reduce the risk of cancer.(35) Others merely proclaim the presence of beta-carotene in
functional foods and trust that the health-conscious consumer will make the connection
independently.

One of the first companies to promote beta-carotene in functional foods was Coca-Cola,
which introduced VegitaBeta(36) in 1991.(37) VegitaBeta is an orange-colored soft drink consisting
primarily of water and sugar. The product contains 3mg of beta-carotene per 100ml serving; an
entire bottle contains 4.8mg. Although the product contains less than 10% juice, the label is filled
with pictures of vegetables such as carrots, and fruits such as oranges, apples, acerola, and, prunes
that naturally contain beta-carotene. The label states Easy way to obtain nutrition, VegitaBeta is
a health-supporting drink that uses five materials [vegetables and fruits]. The beverage carries the
trade mark Daily Care with an explanation that Daily Care is a symbol of products that support a
healthy lifestyle. While VegitaBeta contains a small amount of juice from vegetables and fruits
that contain beta-carotene, the 4.8 mg of beta carotene in one bottle of the beverage is added in
supplement form according to company officials.

The marketing of beta-carotene as an additive to foods became popular in the early 1990s
after several large epidemiological studies found that people who ate a diet rich in fruits and
vegetables containing beta-carotene had lower rates of cancer. However, more recent clinical trials
found that beta-carotene in supplement form does not provide the same benefits as fruits and
vegetables rich in the nutrient.(38) Those studies found that beta-carotene in supplement form does
not reduce the risk of cancer and might even increase the risk of lung cancer in smokers.(39)

Notwithstanding these studies, Coca-Cola and other companies continue to market beta-carotene fortified soft drinks as health foods. The promotion of such products demonstrates the
need for making the FOSHU system mandatory for all products making express or implied health
claims.

Other health food products may be harmless, but useless. For example, the JHNFA certifies
products containing DHA, an ingredient in many non-FOSHU-approved foods that claims to
vitalize the brain, improve memory and learning ability, and make you smart.(40) By the end of
1997, it was being used in almost 50 products ranging from beverages to DHA-fortified eggs. DHA
is docosahexaenoic acid, a fatty acid found in fish. Evidence suggests that newborns  especially
premature infants  may need DHA for optimal brain and eye development. Breast milk typically
supplies adequate amounts of DHA. However, there is little evidence that DHA provides any
benefits for people whose brain and eye tissues are already developed.(41) A few studies showed that
people with depression or Alzheimer's disease have lower DHA levels, but it is not known whether
that is a cause or a result of such disorders. Studies on DHA's impact on short-term memory and
concentration are under way, but so far no results have been published.

It is often difficult for the consumer to differentiate such certified "health foods" from
products sold in compliance with the FOSHU approval system.(42) Both types of products carry an
official looking seal indicating that they can improve health. According to the MHW, however,
many consumers do not recognize the MHW's official FOSHU mark.(43) Thus, consumer confusion
may result. This confusion may be compounded by the deference that the MHW gives to studies
published in the JHNFA journal. The close relationship between the ministry and the association
adds an aura of respectability to JHNFA certified products even though some standards set by the
JHNFA are of questionable value. Even valid standards set by the JHNFA apply only to members of the association  other
companies follow neither industry nor government standards.(44) The absence of adequate regulation
of health foods sold outside the FOSHU system has led to a number of problems. The National
Consumer Information Network System (PIO-NET), the network of local consumer centers around
the country, has received large numbers of complaints regarding chlorella (a single-celled green
algae), one of the most popular health foods sold in Japan. It is promoted on the basis of such
claims as cleans blood, cures atopic dermatitis, and improves health conditions.(45)

Between April 1986 to December 1995, 8,081 complaints were filed with PIO-NET.

More than 2,000 of those complaints concerned physical injury from taking chlorella products or
complaints concerning lack of efficacy (the remainder of the complaints primarily involved abusive
sales practices); 724 complaints about chlorella involved significant health problems including
complaints of diarrhea, rash, and nausea; 31 cases involved hospitalization of consumers that lasted
more than one month.(46) While those problems have not been proven to have been caused by
chlorella, they likely represent only a small fraction of problems attributed to the algae because
many cases may go unreported.